FDA committee recommends approval of Abbott's Trilipix, statin combination

ABBOTT PARK, Ill. — A Food and Drug Administration advisory committee has voted to recommend that the FDA retain approval of an Abbott drug for high cholesterol in combination with a statin.

The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee met Thursday to discuss whether to recommend continued FDA approval of Trilipix (fenofibric acid) in combination with simvastatin in patients with mixed dyslipidemia and a high risk of heart disease. The FDA is not bound by advisory committee votes, but usually follows them.

Results from the “ACCORD Lipid” study had raised concerns about the safety and efficacy of combining the drug with a statin, showing no significant difference between patients treated with Trilipix and simvastatin versus those treated with placebo and simvastatin, and an analysis of the data indicated that women who took the combination experienced more heart attacks than those in the placebo group, but the clinical significance of the finding was unclear at the time.

“Abbott appreciates the committee’s recognition that the totality of data, including 'ACCORD Lipid,' supports retaining the co-administration indication for Trilipix in appropriate patients,” Abbott VP global pharmaceutical clinical development Eugene Sun said. “We also appreciate the request for more clinical data and look forward to further discussions with the FDA.”